Apex Medical Serene User manual

Serene
User’s Manual

CONTENTS
ALTERNATING PRESSURE REDISTRIBUTION SYSTEM
IMPORTANT SAFEGUARDS 1
GROUNDING INSTRUCTIONS 2
INSTRUCTION 4
PRODUCT DESCRIPTION 6
INSTALLATION 10
OPERATION 12
CLEANING 13
STORAGE 14
MAINTENANCE 15
EXPECTED SERVICE LIFE 16
TROUBLE SHOOTING 17
TECHNICAL SPECIFICATION 18
APPEDNIX A: EMC INFORMATION 19
MODEL NO.: 9P-079040
Please read the manual before use

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IMPORTANT SAFEGUARDS
READ ALL INSTRUCTIONS BEFORE OPERATING THIS DEVICE.
DANGER - To reduce the risk of electrocution:
1. Always unplug this product immediately after using.
2. Do not use while bathing.
3. Do not place or store this product where it can fall or be pulled into a tub or sink.
4. Do not place in or drop into water or other liquid.
5. Do not reach for a product that has fallen into water. Unplug immediately.
WARNING - To reduce the risk of burns, electrocution, fire, or injury to persons:
1. Evaluate patients for entrapment risk according to facility protocol and monitor
patients appropriately.
2. Use this product according to the manual and medical professionals’ instructions.
3. Close supervision is necessary when this product is used on or near children.
Electrical burns or choking accident may result from a child swallowing a small part
detached from the device.
4. Use this product only for its intended use as described in this manual. Do not use
other mattress not recommended by the manufacturer.
5. Never operate this product if it has a damaged cord or plug, if it is not working
properly, if it has been dropped or damaged, or dropped into water. Return the
product to a service center for examination and repair.
6. Keep the cord away from heated surfaces.
7. Never block the air openings of this product or place it on a soft surface, such as a
bed or couch, where their openings may be blocked. Keep the air opening free of
lint, hair, and other similar particles.
8. Never drop or insert any object into any opening or hose.
9. Do not modify this equipment without authorization of the manufacturer.
10. Mattress covers have passed skin sensitization and skin irritation test. However, If
you suspect that you may have had or are having an allergic reaction, please
consult a physician immediately.
11. Do not leave long lengths of tubing around the top of your bed. It could lead to
strangulation.
12. Connect this product to a properly grounded outlet only. See Grounding
Instructions.
CAUTION –
1. If there is a possibility of electro-magnetic interference with mobile phones, please
increase the distance (3.3m) between devices or turn off the mobile phone.

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SAVE THESE INSTRUCTIONS
GROUNDING INSTRUCTIONS
DANGER - Improper use of the grounding plug can result in a risk of electric shock.
If repair or replacement of the cord or plug is necessary, do not connect the
grounding wire to either flat blade terminal. The wire with insulation having an
outer surface that is green with or without yellow stripes is the grounding wire.
NOTE - If the repair or replacement of the cord is necessary, please contact a
qualified electrician or serviceman. To reduce the risk of electric shock, do not
modify the cord or plug in any way.
Check with a qualified electrician or serviceman if the grounding instructions are
not completely understood, or if in doubt as to whether the product is properly
grounded.
NOTE, CAUTION AND WARNING STATEMENTS:
NOTE - Indicate some tips.
CAUTION - Indicate correct operating or maintenance procedures in order to
prevent damage to or destruction of the equipment or other property.
WARNING - Calls attention to a potential danger that requires correct procedures or
practices in order to prevent personal injury.

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SYMBOLS
Authorised representative in the European community
Manufacturer
Protected against solid foreign objects of 12,5 mm and greater;
Protection against vertically falling water drops
Temperature limitation/temperature range
Consult operating instructions for use.
"BF" symbol, indicate this product is according to the degree of
protecting against electric shock for type BF equipment
Grounding terminal
Attention, read the accompanying information carefully.
Do Not Bleach
Do Not Iron
Tumble Dry, Normal, Low Heat
Dry clean, Any Solvent Except Trichloroethylene
Machine wash, regular / normal, 95 degrees C (203 degrees F)
Disposal of Electrical & Electronic Equipment (WEEE):
This product should be handed over to an applicable collection
point for the recycling of electrical and electronic equipment.
For more detailed information about the recycling of this
product, please contact your local city office, household waste
disposal service or the retail store where you purchased this
product.

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Introduction
1.
This manual should be used for initial set up of the system and for reference purposes.
1.1 General Information
EN 60601-1
EN 60601-1-2
EN 55011 Class B
IEC61000-3-2
IEC 61000-3-3
EMC Warning Statement
This equipment has been tested and found to comply with the limits for medical
devices to the EN 60601-1-2. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation. This
equipment generates uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to other
devices in the vicinity. However, there is no guarantee that interference will not occur
in a particular installation. If this equipment does cause harmful interference to other
devices, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
￭ Reorient or relocate the receiving device.
￭ Increase the separation between the equipment.
￭ Connect the equipment into an outlet on a circuit different from that to which the
other device(s) are connected.
￭ Consult the manufacturer or field service technician for help.

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1.2 Intended Use
This product is intended:
￭ to help and reduce the incidence of pressure ulcers while optimizing patient
comfort.
￭ for long term home care of patients suffering from pressure ulcers.
￭ for pain management as prescribed by a physician.
The product can only be operated by personnels who are qualified to perform
general nursing procedures and has received adequate training in knowledge of
prevention and treatment of pressure ulcer.
NOTE: Equipment not suitable for use in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide.
NOTE: L’équipement ne peut être utilisé s’il y a risque de mélange d’un
anesthésique inflammable avec l’air ou l’oxygène ou oxyde nitreux.

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Product Description
2.
2.1 Pump & Mattress System
1. Quick Connector for CPR
2. Pump Unit
3. Mattress
4. Mattress Foam Pocket
NOTE: An underlying mattress such foam must be used with Serene system.
2.2 Pump Unit
Front
1. Quick Connector
2. Front Panel
Rear
1. Power Switch
2. Power Socket
3. Fuses
4. Integrated Handle
5. Mounting Bracket
6. Pump Bumper
7. Air Filter

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2.3 Front Panel
1. Comfort Setting
The “Comfort Setting” controls the air pressure output. When the firmness is increased
( ), the output pressure will increase and vice versa ( ) for decreasing air
pressure. A hand check is needed to determine if patient is bottoming out. When a
patients condition has significantly changed reassess appropriateness of product and
comfort setting level
NOTE: Every time the mattress is initialized (inflated), it will automatically go to "Max
Firm" mode to hasten inflation. Once the system is ready to use, the system will go to
Static mode automatically.
NOTE: The Weight Guide indicated on Comfort Level is reference for pressure setting.
Always consult Professionals for the appropriate setting. Check if the pressure is
suitable for the patient by sliding one hand beneath the air cells at the level of the
patient's buttocks. Always leave at least 1” inch space between patient and the cell to
prevent bottoming out.
1
5
2
6
3
4

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2. Therapy Modes
A. Static
All of the air cells are equally inflated at lower pressures to redistribute body mass
over a greater surface area at a constant low pressure.
B. Seat Inflate
The Seat Inflation features additional supports to the patient during head raise
position to prevent bottoming out.
NOTE: When patient in head raised position, or only parts of the body are lying in
mattress, it is recommended to always use Seat Inflate mode and readjust the pressure
setting accordingly to prevent possible bottoming out.
3. On/off
Press On to turn on the unit. Press Off to turn off/standby the unit.
NOTE: The power switch on the side of pump must be turned on.
4. Panel Lock
Should the panel remain untouched for 5 minutes, the panel lock feature will lock the
panel with green LED light on to prevent accident from changing the setting during
normal operation. To unlock, simply by pressing the Panel Lock button for 3 seconds.
5. Max Firm
The system will go into Max Firm mode automatically when the power switch is turned
on. This insures the pump reaches its maximum operating pressure. Once the max
pressure level is reached, the pump will automatically switch into the previous
selected comfort level in STATIC mode, or the user can press the THERAPY button to
return to the previous mode. User can also use this function as full mattress inflation
during patient ingress/egress or normal nursing procedure for better support. There is
a 20 minutes time-out function to return to previous selected therapy setting.

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6. Alarm Mute
Press alarm mute button to temporary suspend the alarm. Should the situation not
resolved within 3 minutes, the low pressure and tech support alarm shall resume to
notify the caregiver.
A. Low Pressure Indicator
When the mattress quick connector is disconnected or mattress pressure is lower
than target pressure for an abnormal period of time, low pressure LED will
continuously lights up with buzzer activated. Once the low pressure problem is fixed,
the control unit resumes operation in the previously set mode.
The Alarm Indicator shows low pressure failure mode. Use the error code when
reporting system failures.
NOTE: The low pressure indicator will not be detected if air cells of mattress are with
small breakage.
B. Power Failure Alarm
During power failure situation, the Power Failure LED light will light on with buzzer.
Press the mute button to disable both buzzer and LED.
C. Service Alarm
The filter required regular inspection and clean to ensure the system is functioning
properly. When the system is up and running for 3 months, the Service Alarm LED will
lights up and flashes to remind of filter inspection. Please relace or clean the filter,
or contact your local dealer or service technician for servie assistance.
Once the filter is relaced or cleaned, pressure MUTE button for 5 sec to reset the
meter for next service reminder.

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Installation
3.
1 2 3
4 5 6
Unpacking the box to inspect for any damage, which may have occurred during
shipment. If there are any damages, please contact your dealer immediately.
1. Place the mattress on top of the bed frame. Please note for the foot end. There are
securing straps on the base of the mattress. Secure the mattress firmly by fixing
the straps to the bed frame, ensure that moving sections of the bed are still free to
move.
WARNING: The Serene mattress must be applied on a underlying mattress or to
insert an foam into the pocket of bottoming cover.
2. Hang the pump onto bed rail (foot-end), and adjust hangers to best upright position
of the pump.
NOTE: Do not place the pump on the floor.

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3. Connect the Quick Connector from air mattress to the pump unit. Make sure the
connector is in the right position as the inserted diagram below. When a "click"
sound is felt or heard, the connection is completed and secured.
NOTE: The pump is only operable when the Quick Connectoris connected to the
system.
NOTE: Check and ensure the air hoses are not kinked or tucked under mattress.
4. Plug the power cord into electrical outlet.
NOTE:
1. Make sure the pump unit is suitable for the local power voltage.
2. The plug is also served to disconnect the device. Do not position the
equipment so that it is difficult to disconnect the device.
NOTE:
1. S’assure que la pompe est compatible au voltage local ou disponible.
2. L’appareil est également muni d’une fiehe de connexion à l’électricité.
CAUTION: The pump can only be applied to the mattress recommended by the
manufacturer. Do not use it for any other purpose.
5. Then turn the main power switch to ON position.
6. After installation, the extra length of the power cord, if any, should be neatly
arranged to avoid any tripping accidents. The EQUIPMENT should be firmly placed at
position where users/doctors can access easily.
Grounding:
Before any connection to the output connectors is made, the unit shall be connected
to a protective earth conductor via the three-core main cable; the mains plug shall be
inserted only into a socket outlet provided with a protective earth contact.
The protective action shall not be negated by the user of an extension cord without
protective conductor.

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Operation
4.
1
2
NOTE: Always read the operating instruction before use.
4.1 General Operation
1. Switch on the main power switch found from the side of the pump and press
on the control panel to turn on the power.
2. The system will automatically go into “Max Firm” mode for a few minutes of inflation.
3. Every time when mattress is first setup for use, It will be forced to execute Maxfirm
for the quickest inflation. The low-pressure indicator (yellow LED) will light up when
the mattress is not fully inflated at initial inflation. If the appropriate pressure is
reached, the low-pressure indicator (yellow LED) will go off.
4. When the initial inflation (Max Firm process) is completed, the system will
automatically enter into Static mode
5. According to the weight and height of the patient, adjust the pressure setting to
the most suitable level without bottoming out.
4.2 CPR
When CPR needs to be performed,
click on the release button on Quick
Connector and quickly detach the
connector from the system to release
air.

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Cleaning
5.
It is important to follow the cleaning procedures to avoid cross contamination. Be sure
to clean the surface in a dry and dust free environment. Wipe down the pump unit with
a damp cloth pre-soaked with a mild detergent. Avoid contact with dust and proximity
to dusty areas. Make sure that any cleaning agents you use will not harm or corrode the
plastic casing on the pump unit. If your doctor or medical facilities have other special
cleaning instruction, please follow the professional instruction.
CAUTION: Do not immerse or soak pump unit in liquids.
WARNING: Do not remove the housing of the pump to avoid the electrical shock. All
disassembly or repair should be done by professional technicians.
CAUTION: The pump does not need oil lubrication; please do not dissemble the
system.
Cover Material : Silver+ Stretch
Cover Material : Stretch
Wipe-down the mattress unit with a damp cloth pre-soaked with warm water
containing a mild detergent, or chlorine bleach followed by an approved intermediate
level disinfectant. Also the mattress top cover can be completely removed for laundry
with water temperature up to 95°C; however, it is recommended that the user still
check with local policy to determine the time/ temperature ratio required to achieve
thermal disinfection. The cover may also be cleaned using sodium hypochlorite diluted
in water. After cleaning, please avoid dust and proximity to dusty areas and all parts
should be air dried thoroughly before use.
CAUTION: Do not use phenolic based products for cleaning.
CAUTION: After cleaning, dry the mattress without direct exposure of sunlight.

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Storage
6.
1. To quickly deflate the mattress for storage, click on the release button on the Quick
Connector
2. Roll from the foot end towards the head end with CPR valve open, and make sure
the tubing is not kinked.
3. Foot-end strap can then be stretched around the rolled mattress to prevent
unrolling. Fasten the buckle strap to secure the packed mattress.
4. The power cord could be wrapped around the pump bumper on the back of pump,
pack the pump with protective package.
5. Place the whole system into the carrying bag.
NOTE: Do not kink, crease or stack the mattresses and do not store the system in
direct sunlight, high temperature or moisture area.

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Maintenance
7.
7.1 General
1. Check main power cord and plug if there are abrasions or excessive wears.
2. Check mattress cover for signs of wear or damage. Ensure mattress cover and
tubes are stubbed together correctly.
3. Check the air hoses for any kink or break. For replacement, please contact your
local dealers.
7.2 Fuse Replacement
1. Disconnect the plug form mains power
when a blown fuse is suspected.
2. Use a proper tool to remove the cover of
the fuse holder.
3. Insert a new fuse of the correct rating in,
and replace the fuse holder back to correct
position. The fuse should be rated as T3.15A
/250V type.
7.3 Air Filter Replacement
1. Replace the air filter located at the side of
pump.
2. The filter is reusable and can be washed
gently with a mild detergent and water. Air dry
the filter before use.
3. Check and replace air filter regularly if
environment is dirty.

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7.4 Rechargeable Battery
1. The rechargeable battery is designed to support power failure alarm. To check if the
rechargeable battery has been drained out, unplug the power cord and see if the
Power Failure indicator will light up along with buzzer last for a few minutes.
2. If the Power Failure Alarm is unable to work or the battery might need to be replaced
(approximate life expectancy 6 months), please contact your dealer or notify the
technician for replacement.
Expected Service Life
8.
The products are intended to offer safe and reliable operation when use or installed
according to the instructions provided by Apex Medical. Apex Medical recommends that
the system be inspected and serviced by authorized technicians if there are any signs
of wear or concerns with device function and indication on products. Otherwise, service
and inspection of the devices generally should not be required.

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Trouble Shooting
9.
Q.1 Q1 Power is not ON
‧ Check if the plug is connected to mains.
‧ Check for a blown fuse.
Q2 Low Pressure Alarm is on
‧ Check if the Quick Connector is tightly secured.
‧ Check if all tubing connections along mattress are secured.
‧ Check if the air hoses are kinked or broken
When the low pressure alarm is activated, the alarm indication code is indicating in
which mode the situation occurred.
E1: System in normal operation
E2: System is just turned on and in initial inflation.
Q3 Power Failure Alarm is on
‧ Check if the power is suddenly shut down.
‧ Check if the power cord is connected properly.
Q4 Patient is bottoming out
‧ Pressure setting might be inadequate for the patient, adjust comfort range 1 to 2
levels higher and wait for a few minutes for best comfort.
Q5 Mattress form is loose
‧ Check if all the snap buttons or straps of mattress are all securely fastened.
‧ Check if the mattress is fixed to the bed frame by straps.
Q6 Service light is on
‧ This indicates that the system is up and running for 3 months and needs filter
inspection.
‧ Inspect the filter to clean or replace a new one.
If the above information does not solve your problems, please contact your local agent
directly. They might require a technician to take care the problem.

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Technical specification
10.
PUMP
Power Supply (Note: See rating label
on the product) AC 220-240V, 50/60 Hz, 3A
Fuse Rating T3.15AL 250V
Dimension (L x W x H) 34 x 16.3 x 23.5 (cm) or 13.4” x 6.4” x 9.3”
Weight 5 kg or 11.02 lb
Classification
Class I, Type BF,
IP21
Applied Part: Air Mattress
Not suitable for use in the presence of a flammable
anesthetic mixture (No AP or APG protection)
ENVIRONMENTAL INFORMATION
Environment
Temperature
Operation: 10° C to 33° C (50° F to 91° F)
Storage: -15° C to 50° C (5° F to 122° F)
Shipping: -15° C to 70° C (5° F to 158° F)
Humidity
Operation: 10% to 90% non-condensing
Storage: 10% to 90% non-condensing
Shipping:10 % to 90% non-condensing
Operating Altitude 2000 m (Maximum)
MATTRESS
Model 8” Mattress Replacement
Dimension (L x W x H) 200 x 90 x 20.3cm / 78.7" x 35.4" x 8"
Weight 7.5 kgs / 16.5 lbs
Maximum Weight Capacity 200 kgs / 440 lbs
NOTE :
1. Consult the distributor or EU representative for further technical documents.
2. The specification is also suitable for other areas operating with same power supply.
3. Mattress dimension and weight is measured without foam cushion
4. The manufacturer reserves the right to modify the specification without notice.